Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Ayurvedic and Unani Tibbia College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients of any gender aged 35 to 65 years diagnosed with Type 2 DM. Fasting Blood sugar 126-179 mg/dl. Glycosylated Hemoglobin (HbA1c) 6.5- 7.9% Subjects willing to provide written informed consent and able to come for follow up on scheduled visits.
Exclusion criteria
Exclusion criteria: Individuals diagnosed with type 1 DM. Subjects not taking any oral hypoglycemic drugs or insulin therapy. Individuals with type 2 DM with poor control (HbA1C greater than or equal to 8 %). Subjects suffering from the acute and chronic complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, diabetes ketoacidosis, hyperglycemic coma, peripheral artery disease, etc. which require emergency management. Subjects with history of any cardiovascular disease such as coronary artery disease, congestive heart failure, Hypertension, valvular heart disease , etc. Subjects with comorbidities such as Bronchial Asthma, COPD, Cerebrovascular Accident, tuberculosis, etc. Subjects having immunocompromised state such as HIV or taking any immunosuppressive medications. Subjects with history or active malignancy. Subjects suffering from any major systemic illness necessitating long term treatment like Rheumatoid arthritis, psychiatric disorders, and endocrinal disorders. Subjects on corticosteroids, beta agonist, estrogen, progestins, antidepressants, antipsychotics etc that may affect glucose metabolism. Subject suffering from any hepatic disorder (SGPT and SGOT more than two times the upper limit of normal) Subjects suffering from chronic kidney disease or any renal disorder (serum creatinine greater than 1.2 mg/dL). Pregnant and lactating women. Subjects taking medicines from any other traditional medicine systems for type 2 DM. Subjects with a history of smoking, alcohol intake or any substance abuse. Subjects having hypersensitivity to any of the trial interventions or their ingredients. Subjects who have completed participation in any other clinical trial during the past six months. Any other clinical condition which may compromise the safety of the individual / study participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting blood sugar and post prandial blood sugar from baseline .Timepoint: Day 1, 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1C from baseline. Timepoint: Day 1, 91;Change in health related quality of life assesed through SF12 questionnaireTimepoint: Day 1, 91;Change in grading of symptoms of Madhumeha assessed through Developing guidelines for clinical research methodology in Ayurveda Timepoint: Day 1, 91;Incidence of adverse events if any.Timepoint: Day 1, 91;Change in the laboratory safety parameters (LFT ,KFT, CBC , Lipid profile) from baseline.Timepoint: Day 1, 91 | — |
Countries
India
Contacts
Public ContactDr Sujata Yadav
Ayurvedic and Unani Tibbia College and Hospital
Outcome results
None listed